Coronavirus COVID-19 Vaccines
Updated: January 13, 2021
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COVID-19 Vaccines in Late-Stage Development
- Multiple vaccines are under development.
- Two have been approved for emergency use in several countries (Table 1).
- Ten have been under investigation in Phase 3 trials (Tables 1 and 2), 61 are in clinical trials (Table 3), and 172 in preclinical evaluation.[1]
- For overview of trial design, see Clinical Trial Phases and Definitions
- Among those with the greatest potential for speed are DNA- and RNA-based platforms, followed by those for developing recombinant-subunit vaccines.
- RNA and DNA vaccines can be made quickly because they require no culture or fermentation, instead using synthetic processes.
Developer | # in | Phase 3 | Emergency | # | Spacing | Vaccine | Storage |
| 44k | 95%[2] | US: 11-Dec[5] EU: 22-Dec[6] | 2 | 21 | mRNA | -70ºC |
| 30k | 94%[7] | US: 18-Dec[8] CA: 23-Dec[9] EU: 06-Jan[10] UK: 08-Jan[11] | 2 | 28 | mRNA | 2–8ºC |
| 24k | UK: 30-Dec[14] AR: 30-Dec IN: 03-Jan MX: 04-Jan | 2 | 28 | Adenovirus | 2–8ºC | |
| 60k | 1 | - | Adenovirus | 2–8ºC | ||
| 45k | 2 | 21 | Protein Subunit | 2–8ºC | ||
Sinovac | 26k | 2 | 14 | Inactivated | 2–8ºC | ||
Sinopharm | 50k | 2 | 21 | Inactivated | |||
Bharat Biotech | 25k | Not yet reported | IN: 03-Jan | 2 | 14 | Inactivated | |
CanSino Biologics | 40k | 1 | - | Adenovirus | 2–8ºC | ||
Gamaleya Research Institute | 40k | 2 | 21 | Adenovirus | -18ºC | ||
Trial = # of Phase 3 trial participants; Phase 3 Efficacy = Vaccine Efficacy/Effectiveness (reduction in disease among the vaccinated group); Emergency Approval = Date of Emergency Use Authorization (EUA); # = Number of Doses Required; US = United States; UK = United Kingdom; CA = Canada; EU = European Union; AR = Argentina; IN = India; MX = Mexico
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Recent News
RECENT UPDATES
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Developer | Phase 1* | Phase II | Phase III |
Pfizer / BioNTech/ | NCT04368728 | NCT04537949 | NCT04537949 |
Moderna/ NIAID | NCT04283461 | ||
University of Oxford/ AstraZeneca | NCT04324606 | NCT04516746 | |
Sinovac | NCT04383574 | ||
Wuhan Institute of Biological Products/ Sinopharm | ChiCTR-2000031809 | ||
Beijing Institute of Biological Products/ Sinopharm | ChiCTR-2000032459 | ||
Bharat Biotech | |||
CanSino Biological Inc/ Beijing Institute of Biotechnology | NCT04313127 | NCT04341389 | |
Gamaleya Research Institute | NCT04437875; | ||
Janssen Pharmaceutical Companies | |||
Novavax | NCT04368988 | ||
*Trials spanning Phase 1 and 2 represent Phase 1/2 trials. |
COVID-19 Vaccines in Clinical Trials
Developer | Platform | Type | Current stage |
| RNA | LNP-encapsulated mRNA (mRNA-1273) | Phase 3 NCT04470427; Positive final results.[15],[22] Phase 2 NCT04405076 Phase 1 NCT04283461; Results in NEJM[25],[23] |
| RNA | 3 LNP-mRNAs (BNT162) | Phase 3 NCT04368728; Positive final results.[27],[26] Phase 1/2 NCT04537949; Results in Nature[29] |
| Non-Replicating Viral Vector | Weakened adenovirus (ChAdOx1-S; AZD1222) | Phase 3 NCT04516746; Positive interim results.[12] Phase2b/3 NCT04400838 Phase 1/2 PACTR202006922165132; 2020-001072-15; Results in Lancet[48] |
Sinovac | Inactivated | Inactivated + alum (CoronaVac; formerly PiCoVacc) | Phase 3 NCT04456595 Phase 1/2 NCT04383574 ; NCT04352608; Results in Science[46] |
Wuhan Institute of Biological Products/ Sinopharm | Inactivated | Inactivated | Phase 3 ChiCTR2000034780 Phase 1/2 ChiCTR2000031809; Results in JAMA[41] |
Beijing Institute of Biological Products/ Sinopharm | Inactivated | Inactivated (BBIBP-CorV) | Phase 3 ChiCTR2000034780 Phase 1/2 ChiCTR2000032459 |
CanSino Biological Inc./ Beijing Institute of Biotechnology | Non-Replicating Viral Vector | Adenovirus Type 5 Vector (Ad5-nCoV) | Phase 3 NCT04526990; NCT04540419 Phase 2 NCT04341389; Results in Lancet[42] Phase 1 NCT04313127; Results in Lancet[48] |
Gamaleya Research Institute | Non-Replicating Viral Vector | Adenovirus-based (Gam-COVID-Vac; Гам-КОВИД-Вак) | Phase 3 NCT04530396 Phase 1 NCT04436471; NCT04437875; Results in Lancet[39] |
Anhui Zhifei Longcom Biopharmaceutical/ Institute of Microbiology, Chinese Academy of Sciences | Protein Subunit | Adjuvanted recombinant protein (RBD-Dimer) | Phase 2 NCT04466085 Phase 1 NCT04445194 |
Inovio Pharmaceuticals / International Vaccine Institute | DNA | DNA plasmid vaccine with electroporation (INO-4800) | Phase 1/2 NCT04336410; NCT04447781 |
| Protein Subunit | Recombinant SARS CoV-2 glycoprotein nanoparticle vaccine adjuvanted with Matrix M (NVX-CoV2373) | Phase 3 2020-004123-16 Phase 2b NCT04533399 Phase 1/2 NCT04368988; Results in NEJM[37] |
| Non-Replicating Viral Vector | Ad26.COV2.S | Phase 3 NCT04505722 Phase 1/2 NCT04436276 |
Bharat Biotech | Inactivated | Whole-Virion Inactivated | Phase 1/2 CTRI/2020/07/026300 |
Kentucky Bioprocessing, Inc | Protein Subunit | RBD-based | Phase 1/2 NCT04473690 |
Institute of Medical Biology, Chinese Academy of Medical Sciences | Inactivated | Inactivated | Phase 1/2 NCT04470609 Phase 1 NCT04412538 |
| Protein Subunit | S protein (baculovirus production | Phase 1/2 NCT04537208 |
Research Institute for Biological Safety Problems, Rep of Kazakhstan | Inactivated | Inactivated | Phase 1/2 NCT04530357 |
SpyBiotech/Serum Institute of India | VLP | RBD-HBsAg VLPs | Phase 1/2 ACTRN12620000817943 |
Genexine Consortium | DNA | DNA Vaccine (GX-19) | Phase 1 NCT04445389 |
Cadila Healthcare Limited | DNA | DNA plasmid vaccine | Phase 1/2 CTRI/2020/07/026352 |
Osaka University/ AnGes/ Takara Bio | DNA | DNA plasmid vaccine + Adjuvant | Phase 1 JapicCTI-205328 |
Gamaleya Research Institute | Non-Replicating Viral Vector | Adenovirus-based (Gam-COVID-Vac; Гам-КОВИД-Вак) | Phase 1 NCT04436471; NCT04437875 |
Clover Biopharmaceuticals Inc./ GSK/ Dynavax | Protein Subunit | Native like Trimeric subunit Spike Protein vaccine (SCB-2019) | Phase 1 NCT04437875 |
Arcturus/Duke-NUS | RNA | mRNA | Phase 1/2 NCT04480957 |
Vaxine Pty Ltd/ Medytox | Protein Subunit | Recombinant spike protein with Advax™ adjuvant | Phase 1 NCT04453852 |
University of Queensland/ CSL/ Seqirus | Protein Subunit | Molecular clamp stabilized Spike protein with MF59 adjuvant | Phase 1 ACTRN12620000674932p |
Imperial College London | RNA | LNP-nCoVsaRNA | Phase 1 ISRCTN17072692 |
Curevac | RNA | mRNA | Phase 1 NCT04449276 |
Medigen Vaccine Biologics Corporation/ NIAID/ Dynavax | Protein Subunit | S-2P protein + CpG 1018 | Phase 1 NCT04487210 |
People’s Liberation Army (PLA) Academy of Military Sciences/Walvax Biotech | RNA | mRNA | Phase 1 ChiCTR2000034112 |
Medicago Inc./ Université Laval | VLP | Plant-derived VLP | Phase 1 NCT04450004 |
Institute Pasteur/ Themis/ Univ. of Pittsburg CVR/ Merck Sharp & Dohme | Replicating Viral Vector | Measles-vector based | Phase 1 NCT04497298 |
ReiThera/ LEUKOCARE/ Univercells | Non-Replicating Viral Vector | Replication defective Simian Adenovirus (GRAd) encoding S | Phase 1 NCT04528641 |
Instituto Finlay de Vacunas, Cuba | Protein Subunit | RBD + Adjuvant | Phase 1 IFV/COR/04 |
FBRI SRC VB VECTOR, Rospotrebnadzor, Koltsovo | Protein Subunit | Peptide | Phase 1 NCT04527575 |
West China Hospital, Sichuan University | Protein Subunit | RBD (baculovirus production expressed in Sf9 cells) | Phase 1 ChiCTR2000037518 |
University Hospital Tuebingen | Protein Subunit | SARS-CoV-2 HLA-DR peptides | Phase 1 NCT04546841 |
COVAXX | Protein Subunit | S1-RBD-protein | Phase 1 NCT04497298 |
Beijing Wantai Biological Pharmacy/ Xiamen University | Replicating Viral Vector | Intranasal flu-based-RBD | Phase 1 ChiCTR2000037782 |
Vaxart | Non-Replicating Viral Vector | Ad5 adjuvanted Oral Vaccine platform | Phase 1 NCT04563702 |
Ludwig-Maximilians - University of Munich | Non-Replicating Viral Vector | MVA-SARS-2-S | Phase 1 NCT04569383 |
†Adapted from Draft landscape of COVID-19 candidate vaccines. WHO. 22 December 2020.[1] LNP = lipid nanoparticle; RBD = receptor-binding domain; mRNA = messenger RNA; VLP = virus-like particles |
COVID-19 Vaccine Trial Phases and Definitions
Preclinical Testing
In a Preclinical trial, the vaccine is given to animals such as mice or monkeys, typically rhesus macaques (Macaca mulatta), to see if it produces an immune response.
Phase 1
In a Phase I trial, the vaccine candidate is given to a small number of people to test safety and dosage as well as to confirm that it stimulates the immune system.
Phase 2
In a Phase II trial, the vaccine candidate is given to hundreds of people split into different age or risk groups groups to see if the vaccine acts differently in different populations. These trials further test the vaccine’s safety and ability to stimulate the immune system.
Phase 3
In a Phase III trial, the vaccine candidate is given to thousands of people and wait to see how many become infected, compared with those who received a placebo. These trials can determine if the vaccine protects against the coronavirus.
Approval
Regulators in each country review the trial results and decide whether to approve the vaccine or not. During a public health emergency, a vaccine may receive Emergency Use Authorization (EUA) before getting formal approval.
Phase 4
In a Phase IV trial – also known as a postmarketing surveillance trial or a confirmatory trial – the vaccine is monitored for safety, side effects and efficacy after it has been approved and made available to the public.
Warp Speed
The U.S. government’s Operation Warp Speed program is expected to name five or more vaccine projects to receive billions of dollars in federal funding before there’s proof that the vaccines work.
Combined Phases
Some coronavirus vaccines are now in combined phase trials to speed evalutation. For instance, many Phase 1/2 trials are underway to test a vaccine for the first time on hundreds of people.
COVID-19 ClinicalTrials.gov Trials
Feedback
References
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